This trial is active, not recruiting.

Condition diabetes
Treatments accu-chek smart pix software, accu-chek smart pix readout device
Sponsor Hoffmann-La Roche
Collaborator Roche Diabetes Care Deutschland GmbH
Start date May 2014
End date April 2017
Trial size 558 participants
Trial identifier NCT02156349, RD001732


This study is a German, prospective, multicenter, controlled, cluster-randomized, interventional comparative study evaluating the efficacy and benefits of integrated PDM care by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Patients treated by usual customary medical practice (Usual Care)
accu-chek smart pix readout device
Smartpix device for data upload out of blood glucose meter devices
Patients treated with "Integrated personalized diabetes management"
accu-chek smart pix software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)

Primary Outcomes

The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods
time frame: from Baseline to 12 months

Secondary Outcomes

Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - existence of a signed Informed Consent form (before any study procedure) - diagnosed Type 2 diabetes mellitus - age ≥18 years - insulin therapy for ≥6 months: BOT, SIT, CT or ICT - HbA1c ≥7.5% (≥ 58,47 mmol/mol respectively), blood withdrawal for measurement in the last 90 days before study visit 1 (patient's inclusion) - longer-term care (at least for the duration of the 12-month study participation) by the trial site - insured by the statutory health insurance (GKV) as a compulsory member or voluntarily insured member or as a family co-insured member - willing and able to participate in the study and to follow the study procedures, among other things sufficient command of the German language, spoken and written Exclusion Criteria: - Treatment of diabetes with insulin pump (CSII) - Methodic and continuous with the use of particular software for processing of SMBG data - by the patient and at visits in the practice by the physician/diabetes educator - in the past 12 months before study participation.presence of terminal renal failure (eGFR < 15ml/min) / dialysis and/or a loss of sight (visual acuity ≤ 0,05 of the better eye) - Existing tumor illness (primary tumor/local recurrence/ metastases) in the past 5 years before study participation newly diagnosed or treated acutely (hormone, chemo- or radiation therapy). Exception: Basal Cell Carcinoma Within a tumor free time of < 5 years Medical Affairs will decide about individual cases - permanent use of steroids in adrenal suppressant doses, of other immuno-modulatory drugs or chemotherapy - known alcohol and drug abuse and medication abuse - known metabolic disorders and/or disorders or therapies that could lead to or have led to wrong measured results (e.g. with the blood glucose measurement) - existing pregnancy, breast-feeding or plan to become pregnant during study participation - physical illness and/or psychological disorder with the result that the patient cannot implement the medical treatment recommendations independently - dependency relationship to the sponsor or to the investigator, e.g. as a professional colleague or family member

Additional Information

Official title Integrated Personalized Diabetes Management (Integrated PDM): Prospective, Randomized, Controlled Intervention Study for the Evaluation of the Effectiveness and the Benefit of Integrated PDM in the Care of People With Type 2 Diabetes in Diabetes Specialized Medical Practices in Germany (DSP)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.